- Eisai, Inc (Raleigh, NC)
- …plus). Demonstrated experience across applicable quality assurance functions in a GMP setting (eg, batch record review , SOP writing, auditing, batch ... foster effective collaboration across teams.ResponsibilitiesExecute core processes within Quality area: Review manufacturing batch records for completeness,… more
- Aequor (Thousand Oaks, CA)
- …and use of quality systems. Duties include purposeful presence on the floor, electronic batch record review , SOP revision & approval, work order approval, ... of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent functional area… more
- Insmed Incorporated (San Diego, CA)
- …participate in the process execution within a Pilot Plant non-GMP manufacturing environment. Review batch records , SOPs, raw material specifications, ... protocols and author development reports.Demonstrated experience with process validation and scale-down models for biopharmaceutical processes, including interpretation of results and reporting that stands up to regulatory inspection.Demonstrated expert… more
- Aequor (Houston, TX)
- …and demonstrates ability to read and comprehend GMP documents (ie SOPs, logs, Batch Records ) o Problem solving in a cross-functional setting, and participation ... on identified recurring root cause. Serves as the Quality Record (PR) Subject Matter Expert (SME), Level I, for...to read and comprehend GMP documents (ie SOPs, logs, Batch Records ) Computer Skills Proficient in the… more
- Merck & Co. (Rahway, NJ)
- …semi-automated and automated equipment, conduct functional testing, assist in clinical batch manufacture as an equipment subject matter expert, assist with ... team with authoring relevant SOPs and specifications to enable clinical batch manufacture.Interface with key stakeholders within the design team, molding team,… more
- Repligen (Hopkinton, IA)
- …and file records appropriately.Process requests and generates labels and batch records for production.Documentation Archival, on and off-site.Assist and ... timely manner while also serving as a resource for the review of quality documentation received from interdepartmental sources.ResponsibilitiesWorks with subject… more
- Merck & Co. (Durham, NC)
- …all Good Manufacturing Practices (GMPs), safety, and environmental regulations.- Review and approve automation documents, preventive maintenance, and SOPs to ... Information TechnologyPreferred Experience and Skills:Experience in-PLCs, SCADA, DCSs, MES, Batch Operations (S88/S95), IT, and OEM.Ability to perform aseptic… more
- Eisai, Inc (Exton, PA)
- …and preventive actions.6. Oversee and coordinate the preparation of bill of materials, batch records , SOPs, and close-out reports for Biologics Pilot Plant ... and technologies, working with R&D and CMO personnel. Provide technical support and document review for phase III and PV at CMOs at the company's discretion.5. Lead… more
- Lilly (Pleasant Prairie, WI)
- …operations to ensure regulatory approval of the facility. **Responsibilities:** + Performs batch records review for Component Preparation, Formulation, ... the pharmaceutical or medical device industry in QA roles + Previous batch review and disposition experience + Ability to make technical decisions, provide… more
- Actalent (Bridgeton, MO)
- …with regulatory expectations. Essential Skills + Quality assurance experience with a focus on batch record review and GMP compliance. + 2-4 years of ... and maintaining high standards of quality and accountability. Responsibilities + Review and understand batch records , manufacturing protocols,… more
- ThermoFisher Scientific (Greenville, NC)
- …Analysis to support deviation investigations of moderate to high complexity + Performs quality batch record review + Aids in identification of continuous ... operations including manufacturing, filling, packaging and inspection, and associated non batch specific activities in for both commercial and product development… more
- ThermoFisher Scientific (Greenville, NC)
- …Analysis to support deviation investigations of moderate to high complexity + Perform quality batch record review + Aid in identification of continuous ... operations including manufacturing, filling, packaging and inspection, and associated non batch specific activities in for both commercial and product development… more
- Lilly (Durham, NC)
- …product released to the market meets applicable GMP standards. **Responsibilities:** + Review related batch records associated with parenteral manufacture, ... to make life better for people around the world. The Quality Assurance Batch Disposition team assures patients worldwide of safe and efficacious drug and device… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …completion and delivery of completed batch records to IPQA and Batch Record review . + Facilitate proper GDP batch record corrections ... Operations BPR Lead is responsible for the real time batch record review program in...record cycle completion tracking and adherence. + Request batch records in advance to plan for… more
- Charles River Laboratories (Rockville, MD)
- …with all applicable internal and external requirements. The QA Specialist II will compile the batch record review records and batch disposition ... or walkthrough of manufacturing and support areas, including in-process batch record review for adherence...adherence to internal procedures and industry best practices * Review executed batch production records … more
- Novo Nordisk (Bloomington, IN)
- …+ Assist with revision of GMP documentation such as Standard Operating Procedures, Master Batch Record review and SMPs + Initiate deviations as required ... Perform audits of manufacturing and support areas, including in-process batch record review for adherence...and approval of project related documents such as Master Batch Production Records , technical transfer, and process… more
- Curia (Albuquerque, NM)
- …primary quality assurance contact for CURIA-Albuquerque clients + Responsible for ensuring batch records have been thoroughly reviewed before product disposition ... improvement initiatives + Will provide quality training related to batch review , sitewide + Read/interpret SOPs to...pressure to meet customer and business deadlines associated with batch record lot release Other Qualifications: +… more
- PCI Pharma Services (Rockford, IL)
- …to ensure compliance standards are met and maintained. Facilitates customer questions for Batch Record review and Documentation Updates. Maintains a positive ... organizing internal and customer approval of batch records and specifications. + Assist with performing record...information. + Assist in the preparation of annual product review data. + Assist with generating and presenting quality-related… more
- Novo Nordisk (Bloomington, IN)
- …+ Assist with revision of GMP documentation such as Standard Operating Procedures, Master Batch Record review and SMPs + Initiate deviations as required ... Perform audits of manufacturing and support areas, including in-process batch record review for adherence...and approval of project related documents such as Master Batch Production Records , technical transfer, and process… more
- Mallinckrodt Pharmaceuticals (St. Louis, MO)
- …intent to correct record errors in manufacturing process documentation that includes batch record review and documentation issue resolution. This role is ... adhered to. Job Description ESSENTIAL FUNCTIONS : + Execute batch record review and document...complex calculations and formulas + Ability to focus and review batch records for an… more
